Job Title: Manufacturing Engineer

Essential Skills

• Experience with blister packaging machinery and processes, including thermoforming, filling, lidding, printing, and heat sealing.
• Blister Packaging Machine Experience (5+ years).
• Expertise in Manufacturing and Process Engineering.
• Knowledge of GMP and cGMP standards.
• Experience in PharmaWorks equipment and Vision Systems, including Keyence.
• Associates or Bachelors in Engineering.
• Industry experience in Tablet, OTC, Medical Device, Food (Gum), or Pharma.

Additional Skills & Qualifications

• Capability to be a key player in the company's growth in blister packaging offerings.
• Experience in integrating and sourcing components from external tooling and film suppliers.
• Ability to monitor and recommend improvements for equipment performance.

Job Description

The Manufacturing Engineer is responsible for supporting blister packaging machinery and related packaging processes. The role involves coordinating equipment selection, installation, and qualification while ensuring compliance with cGMP standards and internal SOPs. The position involves collaborating closely with Engineering, Validation, Operations, and Maintenance teams to bring new machinery online, support product launches, and drive continuous improvement in packaging processes.

Responsibilities

• Coordinate projects related to new equipment selection, installation, and qualification.
• Assemble and lead cross-functional technical and operational teams to ensure timely and budget-conscious project execution.
• Plan and execute IQ/OQ/PQ protocols for new equipment and processes.
• Support new product launches by ensuring packaging and processing equipment is ready and compliant.
• Provide hands-on engineering support for blister packaging machinery, including thermoforming, filling, lidding, printing, and heat sealing.
• Monitor equipment performance and recommend improvements.
• Assist with installation, setup, and basic troubleshooting of packaging equipment and tooling.
• Work with external tooling and film suppliers to source and integrate components.
• Maintain documentation for equipment specifications and collaborate with the Validation Engineer.
• Establish efficient equipment setup procedures and operational standards.
• Evaluate current process metrics and identify areas for improvement.
• Support secondary packaging operations such as cartoning, collation, and downstream printing.
• Contribute to cleanroom integration and expansion efforts (Class 8 environment) as expansion happens.
• Assist with technical writing and documentation for the Engineering group.